NCT04244851

Brief Summary

Malnourished patients are at risk of many complications, including infections, pressure ulcers and readmissions. Little is known about their care pathway after hospital discharge. This study aims to determine care pathways of malnourished patients after hospital discharge and to determine what they need to better take care of their malnutrition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

February 4, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2021

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2021

Completed
Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

December 13, 2019

Last Update Submit

June 11, 2026

Conditions

Keywords

Malnutrition,qualitative study

Outcome Measures

Primary Outcomes (1)

  • evolution of malnutrition after hospital discharge

    Malnutrition diagnostic criteria defined by the French Health Authority : * If age ≥ 70 years old : weight loss ≥ 5% within 1 month and/or ≥ 10% within 6 months and/or BMI \< 21 kg/m² and/or serum albumin level \< 35 g/l * If age \< 70 years old: weight loss ≥ 5% within 1 month and/or ≥ 10% within 6 months and/or BMI \< 18,5 kg/m² level

    3 months after discharge

Secondary Outcomes (7)

  • Describe the path of care following the hospitalization of patients diagnosed with malnutrition at the hospital

    3 months after discharge

  • Evaluate appropriation of patient regarding malnutrition

    3 months after discharge

  • Evaluate the perception of patient regarding malnutrition

    3 months after discharge

  • Evaluate expectations of patient regarding malnutrition

    3 months after discharge

  • Evaluate the needs of health professionals regarding undernutrition

    3 months after discharge

  • +2 more secondary outcomes

Study Arms (1)

Malnourished patients

Malnourished patients

Other: Malnourished patients

Interventions

Data of included patients will be recorded during hospitalization using medical charts. Every patient will be contacted by phone 3 months after hospital discharge. A sample of patients and their caregivers will be interviewed to better understand their perception of malnutrition and what they need to better take care of malnutrition.

Malnourished patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Malnourished patients diagnosed during their hospitalization in the post-emergency unit of Rennes Universisty Hospital

You may qualify if:

  • Malnourished patients, hospitalized in the post-emergency unit during the study period, according to the malnutrition diagnostic criteria defined by the French Health Authority :
  • age ≥ 70 years old: weight loss ≥ 5% within 1 month or ≥ 10% within 6 months and/or BMI \<21 and or serum albumin level \< 35 g/l
  • age \< 70 years old : weight loss ≥ 5% in 1 month or ≥ 10% in 6 months or ≥ 10% compared to the usual weight before the onset of the disease; or BMI \<18.5 kg / m2
  • refusing to participate in the study
  • age \< 18 years old
  • patients under tutorship or guardianship
  • patients living in retirement home
  • Patients without a fixed address

You may not qualify if:

  • patients transferred in another unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2019

First Posted

January 28, 2020

Study Start

February 4, 2020

Primary Completion

April 4, 2021

Study Completion

April 12, 2021

Last Updated

June 12, 2026

Record last verified: 2026-06

Locations